August 6th 2025
Supporting data for the accelerated approval of dordaviprone come from 5 open-label trials in H3 K27M-mutant diffuse midline glioma.
FDA Grants Orphan Drug Designation to Tirabrutinib in Primary CNS Lymphoma
March 29th 2023Investigators are assessing tirabrutinib, which received orphan drug designation from the FDA, as a treatment for patients with relapsed or refractory primary central nervous system lymphoma in the phase 2 PROSPECT study.
Signaling Pathways in the Relapse of Glioblastoma
Javier Orozco-Mera, MD, FACS, MSc, and colleagues assess the signaling pathways and molecular mechanisms involved in the relapse of glioblastoma.
FDA Decides Not to Approve 131I-Omburtamab for Neuroblastoma With CNS/Leptomeningeal Metastases
December 5th 2022The FDA has followed the recommendation of its Oncologic Drugs Advisory Committee and issued a complete response letter denying approval to 131I-omburtamab as a treatment for central nervous system and leptomeningeal metastases stemming from neuroblastoma.
Chemo Delivered Via Subcutaneous Catheter-Pump System May Safely and Effectively Treat Glioblastoma
November 15th 2022Pulsatile, convection-enhanced delivery of topotecan using a novel subcutaneous catheter-pump system implanted into the brain showed promising efficacy signals in patients with glioblastoma, according to findings from a phase 1b clinical trial.
FDA’s ODAC Casts 16 to 0 Vote Against Omburtamab in Pediatric Metastatic Neuroblastoma
November 3rd 2022Members of the FDA’s Oncologic Drugs Advisory Committee indicated there isn’t enough evidence to definitively confirm the overall survival benefit of 131I-omburtamab in pediatric patients with central nervous system or leptomeningeal metastases stemming from neuroblastoma.
ASTRO Releases Clinical Guidelines on the Treatment of IDH-Mutated Grade 2/3 Diffuse Glioma
September 8th 2022Guidelines from the American Society for Radiation Oncology on the use of radiation therapy for patients with IDH-mutant glioma included strong recommendations for close surveillance in IDH-mutant, 1p/19q codeleted, WHO grade 2 oligodendroglioma with no high-risk features and adjuvant radiotherapy for those with WHO grade 3 disease.
Laser Interstitial Thermal Therapy Appears to be a Promising Option in New, Recurrent Glioblastoma
August 23rd 2022Results from a multicenter study showed similar median overall survival results with laser interstitial thermal therapy compared with other tumor resection studies that used radiation and chemotherapy followed by laser ablation in patients with IDH wild-type glioblastoma.